Alcohol Use DisordersMBRPNCT02147483
Mindfulness-Based Relapse Prevention for Alcohol Use Disorders in Remission
A study testing Mindfulness Based Relapse Prevention and Treatment as usual in people with Alcohol Use Disorders, run by University of Virginia at 1 site in United States.
Trial summary
We propose to conduct a pilot study that will examine the utility and mechanisms of Mindfulness-Based Relapse Prevention in reducing alcohol consumption, relapse rates, and physiological arousal to stress in adults 21 years of age and older who have met DSM-IV-TR diagnostic criteria for alcohol dependence within the… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Alcohol Use Disorders
- What is being tested?
- Mindfulness Based Relapse Prevention and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females who have given written informed consent
- 21 years of age or older
- DSM-IV-TR diagnosis of alcohol dependence within the last year, but have abstained from drinking for the last thirty days
- Literate in English and able to read, understand, and complete the rating scales and questionnaires accurately, follow instructions, and make use of mindfulness techniques
- Express a wish to remain abstinent from drinking
- Willingness to participate in mindfulness techniques
- Able to attend all clinic visits without interruption
Who cannot join
- Any current Axis I DSM-IV-TR psychiatric disorder other than alcohol or nicotine dependence that, in the clinician's opinion, warrants treatment or would preclude safe participation in the protocol, including, but not limited to: psychosis, schizophrenia, dementia, schizotypal personality disorder, borderline personality disorder, bipolar disorder, primary diagnosis of eating disorder, or chronic suicidality or homicidality
- Current use of Antabuse (Disulfiram) to pharmacologically treat alcohol dependence
- Serious medical comorbidity requiring medical intervention or close supervision, including a history of dangerous symptoms of withdrawal from alcohol (e.g., seizures), pacemakers, heart transplant, severe arrhythmias, or active atrial fibrillation
- Suicide attempt in the last thirty days
- Gross neurological disease
- Mental retardation, which will be assessed by the PI, postdoctoral fellows, and doctoral students in clinical psychology)
- Minors below the legal drinking age will not be included.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia School of Medicine
Charlottesville, Virginia, 22908
About this study
Official title: Mindfulness-Based Relapse Prevention and Stress Reactivity in Alcohol Dependent Individuals: A Pilot Study
We propose to conduct a pilot study that will examine the utility and mechanisms of Mindfulness-Based Relapse Prevention in reducing alcohol consumption, relapse rates, and physiological arousal to stress in adults 21 years of age and older who have met DSM-IV-TR diagnostic criteria for alcohol dependence within the past year but have abstained from drinking for the last thirty days. MBRP is designed to improve one's ability to self-regulate emotions, thoughts and physical states, thus reducing the need to alleviate associated discomfort through substance use. Participants assigned to the intervention group will receive an 8-week training course of MBRP over a period of nine weeks; participants assigned to the Treatment As Usual (TAU) group will continue treatment as usual, which includes utilizing their own effective strategies to refrain from alcohol use. All participants will be assessed for pretreatment severity of psychological abuse/trauma as well as pre and posttreatment psychosocial functioning (e.g., alcohol consumption, symptoms of depression and anxiety, emotion regulation/coping). The outcome of treatment will be evaluated using a) Timeline Followback drinking data and b) self-report ratings of acquisition of MBRP skills (e.g., state/trait mindfulness, acceptance and awareness, and perceived stress) and depressive and anxiety symptom severity. We hypothesize that participants who receive MBRP training will demonstrate greater acceptance and awareness, reduced cravings, and have a lower likelihood of relapse than participants in the TAU group. It is also expected that MBRP participants will demonstrate greater improvements on psychological measures of depression, anxiety, emotion regulation and coping, and show less perceived stress and physiological arousal to stress compared to TAU participants. Finally, little is known about which types of individuals are most likely to benefit from MBRP. Thus, secondary analyses will help to clarify for whom MBRP may be most effective.
Read the detailed description
Stress exposure increases psychological and physiological arousal and can lead to negative health outcomes. An impaired ability to self-regulate in response to stress contributes to the development of alcohol use disorders and relapse. Mindfulness, a state of present-focused attention and awareness, can be systematically learned through meditative practice to improve self-regulation of emotional, physiological and behavioral responses to stress. Mindfulness meditation further facilitates a balance of mind and body thereby increasing one's ability to respond proactively and effectively to daily events. Research evidence suggests a strong association between mindfulness and positive indicators of well-being which include reductions in fear, anxiety, anger, and better physiological recovery from stress.
Given the importance of self-regulation in the development and progression of alcohol use disorders and relapse, a new approach to substance use treatment, Mindfulness-Based Relapse Prevention (MBRP), was developed. Traditionally, MBRP is an eight-week outpatient treatment program, which integrates core aspects of Relapse Prevention (RP) practices with practices adapted from Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy. The mindfulness practices in MBRP are designed to increase acceptance and tolerance of negative emotions, thoughts and physical states thus reducing the need to alleviate associated discomfort through substance use. MBRP also focuses on increasing awareness of triggers and developing more effective coping behaviors in high-risk situations. Among adults with substance use disorders, MBRP has been found to lead to significantly lower rates of substance use, greater decreases in cravings and greater increases in acceptance and acting with awareness than treatment as usual. MBRP has also been found to facilitate more effective coping and self-regulation of negative emotions during early abstinence.
While research indicates that MBRP is effective in reducing substance use relapse, only preliminary research has examined the influence of MBRP on the physiological mechanisms involved in emotion regulation after exposure to stress. Examining these physiological mechanisms is essential because the central and autonomic nervous systems work together to coordinate the self-regulation of attention, cognition and emotion when stressful cues are encountered, such as when a substance dependent individual is exposed to stressful and/or substance related stimuli. Heart rate variability (HRV) is generally seen as an index of emotion regulation. High frequency HRV reflects parasympathetic activation of the autonomic nervous system and the body's ability to exert cognitive control over attention and emotional responding. Higher levels of HRV are associated with greater emotional and behavioral flexibility, and tend to be associated with better mental and physical health outcomes. In contrast, lower levels of HRV are associated with a wide range of medical and psychiatric disorders, including acute and chronic alcohol ingestion, anxiety and depression. Among alcohol dependent individuals, mindfulness training has been found to increase HRV and lower subjective levels of psychological distress in response to stressful cues in the short-term. The proposed study will be the first to examine the long-term effects of MBRP on HRV and self-reported psychological/behavioral functioning. The results will provide a better understanding of the interplay between the psychological and physical mechanisms involved in relapse and help determine whether MBRP has lasting psychological and physiological benefits. In other words, assessing both the psychological and physiological effects of MBRP will provide a more accurate and comprehensive understanding of how mindfulness aids in promoting self-regulation and relapse prevention. Finally, little is known about which types of individuals are most likely to benefit from MBRP. It is necessary to examine individual characteristics (i.e., baseline levels of HRV, trait mindfulness, substance use, anxiety, depression) to determine which characteristics are associated with positive treatment outcomes in both the short and long-term. This knowledge will enable more efficient and effective delivery of the MBRP treatment.
- Conditions
- Alcohol Use Disorders
- Being tested
- Mindfulness Based Relapse Prevention, Treatment as usual
- Keywords
- Mindfulness, Alcohol use disorders
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Relapse PreventionBehavioural
Mindfulness based relapse prevention therapy provided over eight sessions in person to prevent alcohol relapse.
Treatment as usualBehavioural
Treatment usually provided by clinician
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | Active comparator | Treatment as usual as prescribed by clinician. Receives: Behavioral: Treatment as usual |
| Mindfulness Based Relapse Prevention | Experimental | Mindfulness based relapse prevention will be provided in eight in person sessions to prevent alcohol use. Receives: Behavioral: Mindfulness Based Relapse Prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mindfulness levels
Difference scores on mindfulness scales (session 04 minus baseline, session 08 minus baseline, two-month follow-up minus baseline, four-month follow-up minus baseline) will be calculated. 2 group (intervention, TAU) x 5 interval (baseline, session 04, session 08, two-months follow-up, four-months follow-up) repeated measures analyses of variance (ANOVAs) will be conducted.
Measured: up to 4 months post treatment
Secondary outcomes (1)
cravings; symptoms of depression, anxiety, and perceived stress; obsessive thoughts of alcohol/compulsive drinking
Difference scores (session 04 minus baseline, session 08 minus baseline, two-month follow-up minus baseline, four-month follow-up minus baseline) will be calculated for cravings, symptoms of depression, anxiety, perceived stress, obsessive thoughts of alcohol/compulsive drinking. To test hypotheses 1, 2, and 3, 2 group (intervention, TAU) x 5 interval (baseline, session 04, session 08, two-months follow-up, four-months follow-up) repeated measures analyses of variance (ANOVAs) will be conducted.
Measured: up to 4 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study startAug 2012
- Primary completionJan 2016
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisordersStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Kim Penberthy, University of Virginia
- Investigators
- Jennifer K Penberthy, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147483
- Sponsor's protocol ID
- 16363
- Acronym
- MBRP
- Status last verified
- Apr 2019
- First submitted
- 14 Nov 2013
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Relapse Prevention and Stress Reactivity in Alcohol Dependent Individuals: A Pilot Study
- ClinicalTrials.gov ID
- NCT02147483
- Acronym / sponsor ID
- MBRP / 16363
- Conditions
- Alcohol Use Disorders
- Keywords
- Mindfulness, Alcohol use disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 26 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We propose to conduct a pilot study that will examine the utility and mechanisms of Mindfulness-Based Relapse Prevention in reducing alcohol consumption, relapse rates, and physiological arousal to stress in adults 21 years of age and older who have met DSM-IV-TR diagnostic criteria for alcohol dependence within the past year but have abstained from drinking for the last thirty days. MBRP is designed to improve one's ability to self-regulate emotions, thoughts and physical states, thus reducing the need to alleviate associated discomfort through substance use. Participants assigned to the intervention group will receive an 8-week training course of MBRP over a period of nine weeks; participants assigned to the Treatment As Usual (TAU) group will continue treatment as usual, which includes utilizing their own effective strategies to refrain from alcohol use. All participants will be assessed for pretreatment severity of psychological abuse/trauma as well as pre and posttreatment psychosocial functioning (e.g., alcohol consumption, symptoms of depression and anxiety, emotion regulation/coping). The outcome of treatment will be evaluated using a) Timeline Followback drinking data and b) self-report ratings of acquisition of MBRP skills (e.g., state/trait mindfulness, acceptance and awareness, and perceived stress) and depressive and anxiety symptom severity. We hypothesize that participants who receive MBRP training will demonstrate greater acceptance and awareness, reduced cravings, and have a lower likelihood of relapse than participants in the TAU group. It is also expected that MBRP participants will demonstrate greater improvements on psychological measures of depression, anxiety, emotion regulation and coping, and show less perceived stress and physiological arousal to stress compared to TAU participants. Finally, little is known about which types of individuals are most likely to benefit from MBRP. Thus, secondary analyses will help to clarify for whom MBRP may be most effective.
Detailed description
Stress exposure increases psychological and physiological arousal and can lead to negative health outcomes. An impaired ability to self-regulate in response to stress contributes to the development of alcohol use disorders and relapse. Mindfulness, a state of present-focused attention and awareness, can be systematically learned through meditative practice to improve self-regulation of emotional, physiological and behavioral responses to stress. Mindfulness meditation further facilitates a balance of mind and body thereby increasing one's ability to respond proactively and effectively to daily events. Research evidence suggests a strong association between mindfulness and positive indicators of well-being which include reductions in fear, anxiety, anger, and better physiological recovery from stress.
Given the importance of self-regulation in the development and progression of alcohol use disorders and relapse, a new approach to substance use treatment, Mindfulness-Based Relapse Prevention (MBRP), was developed. Traditionally, MBRP is an eight-week outpatient treatment program, which integrates core aspects of Relapse Prevention (RP) practices with practices adapted from Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy. The mindfulness practices in MBRP are designed to increase acceptance and tolerance of negative emotions, thoughts and physical states thus reducing the need to alleviate associated discomfort through substance use. MBRP also focuses on increasing awareness of triggers and developing more effective coping behaviors in high-risk situations. Among adults with substance use disorders, MBRP has been found to lead to significantly lower rates of substance use, greater decreases in cravings and greater increases in acceptance and acting with awareness than treatment as usual. MBRP has also been found to facilitate more effective coping and self-regulation of negative emotions during early abstinence.
While research indicates that MBRP is effective in reducing substance use relapse, only preliminary research has examined the influence of MBRP on the physiological mechanisms involved in emotion regulation after exposure to stress. Examining these physiological mechanisms is essential because the central and autonomic nervous systems work together to coordinate the self-regulation of attention, cognition and emotion when stressful cues are encountered, such as when a substance dependent individual is exposed to stressful and/or substance related stimuli. Heart rate variability (HRV) is generally seen as an index of emotion regulation. High frequency HRV reflects parasympathetic activation of the autonomic nervous system and the body's ability to exert cognitive control over attention and emotional responding. Higher levels of HRV are associated with greater emotional and behavioral flexibility, and tend to be associated with better mental and physical health outcomes. In contrast, lower levels of HRV are associated with a wide range of medical and psychiatric disorders, including acute and chronic alcohol ingestion, anxiety and depression. Among alcohol dependent individuals, mindfulness training has been found to increase HRV and lower subjective levels of psychological distress in response to stressful cues in the short-term. The proposed study will be the first to examine the long-term effects of MBRP on HRV and self-reported psychological/behavioral functioning. The results will provide a better understanding of the interplay between the psychological and physical mechanisms involved in relapse and help determine whether MBRP has lasting psychological and physiological benefits. In other words, assessing both the psychological and physiological effects of MBRP will provide a more accurate and comprehensive understanding of how mindfulness aids in promoting self-regulation and relapse prevention. Finally, little is known about which types of individuals are most likely to benefit from MBRP. It is necessary to examine individual characteristics (i.e., baseline levels of HRV, trait mindfulness, substance use, anxiety, depression) to determine which characteristics are associated with positive treatment outcomes in both the short and long-term. This knowledge will enable more efficient and effective delivery of the MBRP treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | Active comparator | Behavioral: Treatment as usualTreatment as usual as prescribed by clinician. |
| Mindfulness Based Relapse Prevention | Experimental | Behavioral: Mindfulness Based Relapse PreventionMindfulness based relapse prevention will be provided in eight in person sessions to prevent alcohol use. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females who have given written informed consent
- 21 years of age or older
- DSM-IV-TR diagnosis of alcohol dependence within the last year, but have abstained from drinking for the last thirty days
- Literate in English and able to read, understand, and complete the rating scales and questionnaires accurately, follow instructions, and make use of mindfulness techniques
- Express a wish to remain abstinent from drinking
Key exclusion criteria (7 listed)
- Any current Axis I DSM-IV-TR psychiatric disorder other than alcohol or nicotine dependence that, in the clinician's opinion, warrants treatment or would preclude safe participation in the protocol, including, but not limited to: psychosis, schizophrenia, dementia, schizotypal personality disorder, borderline personality disorder, bipolar disorder, primary diagnosis of eating disorder, or chronic suicidality or homicidality
- Current use of Antabuse (Disulfiram) to pharmacologically treat alcohol dependence
- Serious medical comorbidity requiring medical intervention or close supervision, including a history of dangerous symptoms of withdrawal from alcohol (e.g., seizures), pacemakers, heart transplant, severe arrhythmias, or active atrial fibrillation
- Suicide attempt in the last thirty days
- Gross neurological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Based Relapse PreventionMindfulness based relapse prevention therapy provided over eight sessions in person to prevent alcohol relapse. | Behavioural | Mindfulness Based Relapse Prevention |
| Treatment as usualTreatment usually provided by clinician | Behavioural | Treatment as usual |
Primary outcome
Mindfulness levels
Time frame: up to 4 months post treatment
Difference scores on mindfulness scales (session 04 minus baseline, session 08 minus baseline, two-month follow-up minus baseline, four-month follow-up minus baseline) will be calculated. 2 group (intervention, TAU) x 5 interval (baseline, session 04, session 08, two-months follow-up, four-months follow-up) repeated measures analyses of variance (ANOVAs) will be conducted.
1 secondary outcome
cravings; symptoms of depression, anxiety, and perceived stress; obsessive thoughts of alcohol/compulsive drinking
Time frame: up to 4 months post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer K Penberthy, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Relapse Prevention and Treatment as usual in people with Alcohol Use Disorders, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mindfulness levels (time frame: up to 4 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.